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Uses

Duodenal Ulcer

Short-term (up to 8 weeks) treatment of active duodenal ulcer.

Maintenance of healing and reduction in recurrence of duodenal ulcer.

Conventional antiulcer therapy, including sucralfate therapy, is associated with a high rate of ulcer recurrence (e.g., 60–100% per year) in patients with initial or recurrent duodenal ulcer and documented Helicobacter pylori infection. All such patients should receive anti-infective therapy for treatment of the infection; choice of a particular regimen should be based on current data on optimal therapy.

Efficacy of short-term sucralfate similar to that of cimetidine in adults with duodenal ulcer.

Gastric Ulcer

Short-term treatment of gastric ulcer†.

Conventional antiulcer therapy, including sucralfate therapy, is associated with a high rate of ulcer recurrence (e.g., 60–100% per year) in patients with initial or recurrent gastric ulcer and documented H. pylori infection. All such patients should receive anti-infective therapy for treatment of the infection; choice of a particular regimen should be based on current data on optimal therapy.

Chemotherapy-induced Mucositis

Has been used as an oral suspension† for prevention and treatment of chemotherapy-induced mucositis†. Results have been conflicting; additional study necessary.

Dosage and Administration

General

• Equivalence of sucralfate suspension and tablets not demonstrated.

Administration

Oral Administration

Administer orally on an empty stomach, 1 hour before each meal and at bedtime.

Agitate suspension well prior to administration of each dose.

Antacids may be given as necessary for pain relief but should not be taken within 30 minutes before or after sucralfate. (See Specific Drugs under Interactions.)

NG Tube

Bezoars may form with concomitant use of sucralfate and enteral tube feedings. (See Bezoars under Cautions.)

Dosage

Adults

Duodenal Ulcer

Treatment

Oral

1 g 4 times daily for 4–8 weeks.

Although healing may occur during first 2 weeks of therapy, continue treatment for full 4–8 weeks unless healing is confirmed by radiographic or endoscopic examination.

Maintenance of Healing

Oral

1 g twice daily.

Gastric Ulcer

Oral

1 g 4 times daily.†

Special Populations

Dosage in Hepatic Impairment

No specific dosage recommendations at this time.

Dosage in Renal Impairment

No specific dosage recommendations at this time. (See Renal Impairment under Cautions.)

Geriatric Patients

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.

Cautions

Contraindications

• Manufacturer states that there are no known contraindications to use of sucralfate.

Warnings/Precautions

General Precautions

Although sucralfate may result in complete ulcer healing, it does not alter the post-healing frequency or severity of duodenal ulceration; duodenal ulcer is a chronic, recurrent disease.

Administration Precautions

Do not administer IV; may cause fatal complications, including pulmonary and cerebral emboli.

Bezoars

Formation of bezoars reported, primarily in patients with underlying predisposing medical conditions (e.g., delayed gastric emptying) or those receiving concomitant enteral tube feedings.

Specific Populations

Pregnancy

Category B.

Lactation

Not known whether sucralfate is distributed into milk. Caution if used in nursing women.

Pediatric Use

Safety and efficacy not established.

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; select dosage with caution.

Substantially eliminated by kidneys; assess renal function periodically since geriatric patients are more likely to have decreased renal function.

Renal Impairment

Use with caution in patients with chronic renal failure or those undergoing dialysis; possible impaired excretion of absorbed aluminum.

Possible aluminum accumulation and toxicity (e.g., aluminum osteodystrophy, osteomalacia, encephalopathy) in patients with renal impairment.

Common Adverse Effects

Constipation.